Flexible medical article and method of making the same

• US 10,675,446 B2
• Filed: 05/21/2018
• Issued: 06/09/2020
• Est. Priority Date: 03/14/2012
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Asspv, LLC
• Inventors: Bierman, Steven F.
• Primary Examiner(s): Wollschlager, Jeffrey M
• Application Number:
  US15/985,405
• Publication Number:
  US 20180264234A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/0064 which become stiffer or softer when heated
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: B29C 2071/022 Annealing
• CPC Class Codes: B29C 2791/002 Making articles of definite length, i.e. discrete articles B29C53/40 takes precedence
• CPC Class Codes: B29C 48/0011 combined with compression moulding
• CPC Class Codes: B29C 48/0022 combined with cutting
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/11 comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29C 48/13 Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes
• CPC Class Codes: B29C 48/88 Thermal treatment of the stream of extruded material, e.g. cooling
• CPC Class Codes: B29C 48/91 Heating, e.g. for cross linking
• CPC Class Codes: B29C 48/9105 of hollow articles
• CPC Class Codes: B29C 48/913 externally
• CPC Class Codes: B29C 48/92 : Measuring, controlling or regulating
• CPC Class Codes: B29C 57/02 : Belling or enlarging, e.g. combined with forming a groove
• CPC Class Codes: B29C 71/02 : Thermal after-treatment B29C71/0063 and B29C71/0072 take precedence
• CPC Class Codes: B29D 23/001 : Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2023/00 : Tubular articles B29L2024/00 takes precedence ; catheters B29L2031/7542
• CPC Class Codes: B29L 2023/007 : Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2023/20 : Flexible squeeze tubes, e.g. for cosmetics
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Claims

1. A method for forming a flexible medical article, the method comprising the following steps:

forming a tubular member of a medical article by extruding a polycarbonate urethane copolymer;

annealing the extruded tubular member of the medical article to increase a flexibility of the tubular member of the medical article; and

over-molding a hub onto a first end of the tubular member of the medical article;

wherein the tubular member is annealed sufficiently so as to be capable of bending at an angle up to about 120°

without kinking.

2. The method of claim 1, wherein annealing comprises annealing the tubular member of the medical article at about 120°

C. for about one hour.

3. The method of claim 1, wherein the polycarbonate urethane copolymer is selected to have the property of reduced rigidity when exposed to a temperature of 37°

C.

4. The method of claim 1 further comprising cutting the tubular member of the medical article.

5. The method of claim 1 further comprising flaring the first end of the tubular member of the medical article.

6. The method of claim 1 further comprising forming a second end of the tubular member of the medical article into a tip.

7. The method of claim 1, wherein the tubular member is capable of withstanding pressures up to 300 psi.

8. The method of claim 1, wherein the tubular member is capable of withstanding flow rates of up to 130 ml/min.

9. The method of claim 1, wherein the medical article further comprises a dilator having a dilator shaft extending from a dilator hub, and wherein the tubular member is coaxially disposed on the dilator shaft with the hub juxtaposed the dilator hub.

10. The method of claim 9, wherein the dilator shaft and dilator hub are sized to allow a needle shaft, a guidewire, or both to extend through the dilator shaft and dilator hub.

11. The method of claim 9, wherein the medical article further comprises:

a needle having a needle shaft and a needle hub; and

a guidewire,

wherein the dilator shaft is coaxially disposed on the needle shaft with the needle hub and dilator hub juxtaposed and the guidewire is at least partially disposed in the needle.

12. The method of claim 11, wherein the medical article further comprises a track along which the needle hub travels, the track being attached to the dilator hub.

13. A method for forming a flexible medical article, the method comprising:

annealing a tubular member of a medical article to increase a flexibility of the tubular member of the medical article,

wherein the tubular member comprises a polycarbonate urethane copolymer that is extruded prior to annealing the tubular member of the medical article;

wherein the tubular member is annealed sufficiently so as to be capable of bending at an angle up to about 120°

without kinking.

14. The method of claim 13, wherein annealing comprises annealing the tubular member of the medical article at about 120°

C. for about one hour.

15. The method of claim 13, wherein the polycarbonate urethane copolymer is selected to have the property of reduced rigidity when exposed to a temperature of 37°

C.

16. The method of claim 13 further comprising cutting the tubular member of the medical article.

17. The method of claim 13 further comprising flaring the first end of the tubular member of the medical article.

18. The method of claim 13 further comprising coupling a hub to a first end of the annealed tubular member of the medical article.

19. The method of claim 13 further comprising over-molding a hub onto a first end of the tubular member of the medical article.

20. The method of claim 13 further comprising forming a second end of the tubular member of the medical article into a tip.

21. The method of claim 13, wherein the tubular member is capable of withstanding pressures up to 300 psi.

22. The method of claim 13, wherein the tubular member is capable of withstanding flow rates of up to 130 ml/min.

23. The method of claim 13, wherein the medical article further comprises a dilator having a dilator shaft extending from a dilator hub, and wherein the tubular member is coaxially disposed on the dilator shaft with the hub juxtaposed the dilator hub.

24. The method of claim 23, wherein the dilator shaft and dilator hub are sized to allow a needle shaft, a guidewire, or both to extend through the dilator shaft and dilator hub.

25. The method of claim 23, wherein the medical article further comprises:

a needle having a needle shaft and a needle hub; and

a guidewire,

wherein the dilator shaft is coaxially disposed on the needle shaft with the needle hub and dilator hub juxtaposed and the guidewire is at least partially disposed in the needle.

26. The method of claim 25, wherein the medical article further comprises a track along which the needle hub travels, the track being attached to the dilator hub.